Oxycodone and Acetaminophen

Product NDC
55700-497
Requested package NDC
55700-497-28
11-digit product format
557000497
Labeler code
55700
Product ID
55700-497_8c9196fe-65e3-4e1f-b71b-ae9e08d5a4e7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Oxycodone and Acetaminophen
Dosage form
TABLET
Route
ORAL
Labeler
Quality Care Products LLC
Application
ANDA201972
Marketing category
ANDA
Marketing start
2016-12-01
Marketing end
0000-00-00
Substance
ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE
Active strength
325 mg/1; mg/1
Pharmacologic classes
Full Opioid Agonists [MoA], Opioid Agonist [EPC]
DEA schedule
CII
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage55700-49755700-497-28DDiscontinued by firm2026-08-03

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 10 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Code, Status table
Captured / source dateCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05DDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26DDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31DDiscontinued by firm2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28DDiscontinued by firma1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21DDiscontinued by firmcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10DDiscontinued by firmcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31DDiscontinued by firm302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20DDiscontinued by firmed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10DDiscontinued by firm0efc9e666f02…f202fb6c5f17…
2024-03-11 06:39 UTC · source 2024-03-08IInactivated by FDA1332a3947898…d4bfe170f9cd…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A201972-001OXYCODONE AND ACETAMINOPHENACETAMINOPHEN; OXYCODONE HYDROCHLORIDE325MG;2.5MGTABLET / ORALAA2013-07-15
A201972-002OXYCODONE AND ACETAMINOPHENACETAMINOPHEN; OXYCODONE HYDROCHLORIDE325MG;5MGTABLET / ORALAA2013-07-15
A201972-003OXYCODONE AND ACETAMINOPHENACETAMINOPHEN; OXYCODONE HYDROCHLORIDE325MG;7.5MGTABLET / ORALAA2013-07-15
A201972-004OXYCODONE AND ACETAMINOPHENACETAMINOPHEN; OXYCODONE HYDROCHLORIDE325MG;10MGTABLET / ORALAA2013-07-15

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 4 matching rows.

Application-product, TE code table
Application-productTE code
A201972-001AA
A201972-002AA
A201972-003AA
A201972-004AA

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 5 · 164 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A201972-001OXYCODONE AND ACETAMINOPHEN325MG;2.5MGTABLET / ORALAA2013-07-15011fe1cb6892…
2026-02-19 14:30 UTC2026-02A201972-002OXYCODONE AND ACETAMINOPHEN325MG;5MGTABLET / ORALAA2013-07-15011fe1cb6892…
2026-02-19 14:30 UTC2026-02A201972-003OXYCODONE AND ACETAMINOPHEN325MG;7.5MGTABLET / ORALAA2013-07-15011fe1cb6892…
2026-02-19 14:30 UTC2026-02A201972-004OXYCODONE AND ACETAMINOPHEN325MG;10MGTABLET / ORALAA2013-07-15011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A201972-001OXYCODONE AND ACETAMINOPHEN325MG;2.5MGTABLET / ORALAA2013-07-1531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A201972-002OXYCODONE AND ACETAMINOPHEN325MG;5MGTABLET / ORALAA2013-07-1531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A201972-003OXYCODONE AND ACETAMINOPHEN325MG;7.5MGTABLET / ORALAA2013-07-1531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A201972-004OXYCODONE AND ACETAMINOPHEN325MG;10MGTABLET / ORALAA2013-07-1531067a03dcf5…
2025-08-23 18:47 UTC2025-08A201972-001OXYCODONE AND ACETAMINOPHEN325MG;2.5MGTABLET / ORALAA2013-07-156a471c1ec25d…
2025-08-23 18:47 UTC2025-08A201972-002OXYCODONE AND ACETAMINOPHEN325MG;5MGTABLET / ORALAA2013-07-156a471c1ec25d…
2025-08-23 18:47 UTC2025-08A201972-003OXYCODONE AND ACETAMINOPHEN325MG;7.5MGTABLET / ORALAA2013-07-156a471c1ec25d…
2025-08-23 18:47 UTC2025-08A201972-004OXYCODONE AND ACETAMINOPHEN325MG;10MGTABLET / ORALAA2013-07-156a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A201972-001OXYCODONE AND ACETAMINOPHEN325MG;2.5MGTABLET / ORALAA2013-07-15fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A201972-002OXYCODONE AND ACETAMINOPHEN325MG;5MGTABLET / ORALAA2013-07-15fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A201972-003OXYCODONE AND ACETAMINOPHEN325MG;7.5MGTABLET / ORALAA2013-07-15fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A201972-004OXYCODONE AND ACETAMINOPHEN325MG;10MGTABLET / ORALAA2013-07-15fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A201972-001OXYCODONE AND ACETAMINOPHEN325MG;2.5MGTABLET / ORALAA2013-07-15b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A201972-002OXYCODONE AND ACETAMINOPHEN325MG;5MGTABLET / ORALAA2013-07-15b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A201972-003OXYCODONE AND ACETAMINOPHEN325MG;7.5MGTABLET / ORALAA2013-07-15b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A201972-004OXYCODONE AND ACETAMINOPHEN325MG;10MGTABLET / ORALAA2013-07-15b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A201972-001OXYCODONE AND ACETAMINOPHEN325MG;2.5MGTABLET / ORALAA2013-07-1503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A201972-002OXYCODONE AND ACETAMINOPHEN325MG;5MGTABLET / ORALAA2013-07-1503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A201972-003OXYCODONE AND ACETAMINOPHEN325MG;7.5MGTABLET / ORALAA2013-07-1503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A201972-004OXYCODONE AND ACETAMINOPHEN325MG;10MGTABLET / ORALAA2013-07-1503ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A201972-001OXYCODONE AND ACETAMINOPHEN325MG;2.5MGTABLET / ORALAA2013-07-152680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A201972-002OXYCODONE AND ACETAMINOPHEN325MG;5MGTABLET / ORALAA2013-07-152680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A201972-003OXYCODONE AND ACETAMINOPHEN325MG;7.5MGTABLET / ORALAA2013-07-152680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A201972-004OXYCODONE AND ACETAMINOPHEN325MG;10MGTABLET / ORALAA2013-07-152680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A201972-001OXYCODONE AND ACETAMINOPHEN325MG;2.5MGTABLET / ORALAA2013-07-155bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A201972-002OXYCODONE AND ACETAMINOPHEN325MG;5MGTABLET / ORALAA2013-07-155bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A201972-003OXYCODONE AND ACETAMINOPHEN325MG;7.5MGTABLET / ORALAA2013-07-155bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A201972-004OXYCODONE AND ACETAMINOPHEN325MG;10MGTABLET / ORALAA2013-07-155bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A201972-001OXYCODONE AND ACETAMINOPHEN325MG;2.5MGTABLET / ORALAA2013-07-15d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A201972-002OXYCODONE AND ACETAMINOPHEN325MG;5MGTABLET / ORALAA2013-07-15d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A201972-003OXYCODONE AND ACETAMINOPHEN325MG;7.5MGTABLET / ORALAA2013-07-15d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A201972-004OXYCODONE AND ACETAMINOPHEN325MG;10MGTABLET / ORALAA2013-07-15d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A201972-001OXYCODONE AND ACETAMINOPHEN325MG;2.5MGTABLET / ORALAA2013-07-15d06236e962d9…
2024-10-29 15:01 UTC2024-10A201972-002OXYCODONE AND ACETAMINOPHEN325MG;5MGTABLET / ORALAA2013-07-15d06236e962d9…
2024-10-29 15:01 UTC2024-10A201972-003OXYCODONE AND ACETAMINOPHEN325MG;7.5MGTABLET / ORALAA2013-07-15d06236e962d9…
2024-10-29 15:01 UTC2024-10A201972-004OXYCODONE AND ACETAMINOPHEN325MG;10MGTABLET / ORALAA2013-07-15d06236e962d9…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 164 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A201972-001AA1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A201972-002AA1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A201972-003AA1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A201972-004AA1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A201972-001AA131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A201972-002AA131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A201972-003AA131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A201972-004AA131067a03dcf5…
2025-08-23 18:47 UTC2025-08A201972-001AA16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A201972-002AA16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A201972-003AA16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A201972-004AA16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A201972-001AA1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A201972-002AA1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A201972-003AA1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A201972-004AA1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A201972-001AA1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A201972-002AA1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A201972-003AA1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A201972-004AA1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A201972-001AA103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A201972-002AA103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A201972-003AA103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A201972-004AA103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A201972-001AA12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A201972-002AA12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A201972-003AA12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A201972-004AA12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A201972-001AA15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A201972-002AA15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A201972-003AA15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A201972-004AA15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A201972-001AA1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A201972-002AA1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A201972-003AA1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A201972-004AA1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A201972-001AA1d06236e962d9…
2024-10-29 15:01 UTC2024-10A201972-002AA1d06236e962d9…
2024-10-29 15:01 UTC2024-10A201972-003AA1d06236e962d9…
2024-10-29 15:01 UTC2024-10A201972-004AA1d06236e962d9…

FDA-Initiated Inactive NDC Indexing#

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
55700-497-01EA - Each55700-4972b92b9ae-69a5-4ced-b4de-0b2c79f2220a12017-03-06
55700-497-28EA - Each55700-497998186a5-a2f0-44e8-8a65-8c3c281fa65f12021-10-08
55700-497-30EA - Each55700-497dade9f9e-5d12-4fc6-9d22-e29d7009ec6712017-03-06
55700-497-60EA - Each55700-497e0f7ce7d-286d-4dff-b1f9-e0fe1c44784112017-03-06
55700-497-90EA - Each55700-4975c0bca15-204c-4783-b5f8-6fdf7bc2527512017-03-06

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 4 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Oxycodone and AcetaminophenOXYCODONE AND ACETAMINOPHENAurolife Pharma, LLC69df20d9-b1d5-47dc-9ff0-29987284f8c72025-12-23Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 201972
application number: ANDA201972
Oxycodone and AcetaminophenOXYCODONE AND ACETAMINOPHENBryant Ranch Prepackc12c26be-ba05-4d25-a2bf-f87623c6ae572024-08-09Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 201972
application number: ANDA201972
Oxycodone and AcetaminophenOXYCODONE AND ACETAMINOPHENProficient Rx LPdd4dbe5b-8d07-4a96-a78d-2f20da761dad2019-11-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 201972
application number: ANDA201972
Oxycodone and AcetaminophenOXYCODONE AND ACETAMINOPHENProficient Rx LPdf97ea5a-51df-453b-b1b4-edc74c718ee72019-10-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 201972
application number: ANDA201972

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55700-497-285570004972828 TABLET in 1 BOTTLE (55700-497-28) 28 tablet2021-08-310000-00-00NoNoCurrent